Cell therapy weekly: US FDA program to accelerate COVID-19 therapies

Written by RegMedNet

Also this week: Avectas obtains patent for cell engineering platform and clinical trial starts to tackle COVID-19.

The news highlights:

US FDA program to accelerate COVID-19 therapies
Avectas obtains US patent for cell modification technology
Clinical trial starts to tackle major cause of death in COVID-19 patients

US FDA program to accelerate COVID-19 therapies

The US FDA (MD, USA) has announced an ‘all-hands-on-deck’ approach to tackling the COVID-19 pandemic. With the new Coronavirus Treatment Acceleration Program, the agency plans to cut red-tape and expedite therapies, enabling them to reach critically ill patients as swiftly as possible, while still maintaining safety standards.

“As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of the Department of Health and Human Services (MD, USA) to support potential coronavirus treatments for weeks now,” commented Alex Azar, Department of Health and Human Services Secretary.
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Avectas obtains US patent for cell modification technology

Avectas (Dublin, Ireland) has announced the approval of
its US patent claim (No. 10612042) on the Solupore® delivery platform. Solupore
is a cell engineering platform designed to deliver proteins and nucleic acids
across plasma membranes and has been created specifically with therapeutic
products in mind. In February 2020, Avectas announced a collaboration agreement with
the Centre for Commercialization of Regenerative Medicine (CCRM; ON, CA) to
advance the transition of Solupore to the clinic.

“Our patented cell engineering platform leverages a
new mechanism to permeabilize the cell membrane and to enable the delivery of
therapeutic molecules into the cell, enabling the production of functionally
fitter cells to recognize and attack cancers,” stated Michael Maguire,
Chief Executive Officer of Avectas. “This granted patent is an important
component in our IP portfolio, protecting value in our cell engineering
platform. We look forward to continuing the development of Solupore to address
the tremendous need for a new cell engineering technology for next-generation
cell therapies.”

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Clinical trial starts to tackle major cause of death in COVID-19 patients

Orbsen Therapeutics (Galway, Ireland) has announced the
start of a Phase IIa clinical trial involving the company’s stromal cell
immunotherapy product, ORBCEL. The trial has been approved by the Medical
Health Regulatory Agency (MHRA; London, UK) and will investigate the effect of
the therapy on acute respiratory distress syndrome, a condition that results in
nearly 90% of COVID-19-related deaths.

“The successful completion of ORBCEL’s Phase I
clinical trial, intended to assess ORBCEL safety in patients, confirms our
belief in the potential of Orbsen’s proprietary stromal cell immunotherapy
technologies,” explained Larry Couture, CEO of Orbsen Therapeutics.
“We believe ORBCEL will prove a valuable addition to the arsenal of
therapies to combat the effects of COVID-19.”

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.

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